Compromise US FDA Reform Bills This Week?

Compromise language on three bills changing the US Food and Drug Administration review process for new medicines, drugs and medical devices has been presented by Representative Greenwood, who was last week in negotiations with Health and Human Services Secretary Donna Shalala. A spokesman for Rep Greenwood told the Marketletter that he hoped to have these ironed out by July 26, and to offer the compromise bills for markup this week (starting July 29).

The major changes to HR 3199 which were in discussion last week include:

- provisions that specify the use of third-party reviewers are clarified to provide that the FDA controls their use, accreditation and payment.